Akebia Therapeutics Reports Net Income of $540,000 for Q3 2025, Significant Turnaround from Prior Year

Akebia Therapeutics, Inc. reported net income of $540,000 for the three months ended September 30, 2025, a significant turnaround from the net loss of $20.0 million for the same period in 2024. This improvement was primarily driven by a 60% increase in product revenue, reaching $56.8 million, attributed to the market entry of Vafseo and increased sales volumes of Auryxia. License, collaboration, and other revenue also saw a slight increase of 8%, totaling $2.0 million. The company's income from operations was $4.4 million, compared to a loss of $12.5 million in the prior year, while operating expenses increased by 26% to $44.9 million, mainly due to higher research and development costs.

For the nine months ended September 30, 2025, Akebia reported net income of $6.9 million, a substantial improvement from the net loss of $46.6 million for the same period in 2024. Product revenue increased by 61% to $173.0 million, again driven by Vafseo and Auryxia sales. License, collaboration, and other revenue decreased slightly by 6% to $5.5 million. The company's income from operations was $32.1 million, compared to a loss of $36.2 million in the prior year, while operating expenses increased by 12% to $119.6 million, mainly due to higher research and development costs.

Operationally, Akebia launched Vafseo in the U.S. market in January 2025, securing commercial supply agreements with dialysis organizations covering nearly 100% of dialysis patients. Auryxia, however, lost exclusivity in the U.S. in March 2025, with an authorized generic version now being sold by Mylan Therapeutics, Inc. The company is also exploring potential label expansion opportunities for Vafseo, but has paused plans to initiate the VALOR clinical trial for non-dialysis patients due to lack of alignment with the FDA on trial design. As of September 30, 2025, Akebia had 265,226,038 shares of common stock issued and outstanding.

Looking ahead, Akebia believes its cash resources and anticipated revenues will be sufficient to fund its operating plan for at least the next twelve months. The company expects to finance future cash needs through product and license revenue, including royalties and supply agreements. However, the company acknowledges that failure to achieve anticipated Vafseo revenue projections could affect its liquidity and ability to continue as a going concern. Akebia may also seek additional financing through public or private equity sales, new debt transactions, or strategic transactions. The company also identified a material weakness in its internal control over financial reporting related to accounting for inventory and inventory-related transactions, and is taking steps to remediate this weakness.